GSK PLC (LSE:GSK, NYSE:GSK)'s respiratory syncytial virus (RSV) vaccine has been endorsed by advisors to the US Food and Drug Administration (FDA), who assessed its safety and efficacy in older adults.
The decision puts GSK in direct competition with Pfizer Inc (NYSE:PFE), which has also developed a promising RSV vaccine.
While most advisors on the FDA's Vaccines and Related Biological Products Advisory Committee said that available data supported GSK's approval, some expressed wariness about relying on post-market data to uncover additional safety concerns.
GSK's vaccine was found to be 82.6% effective against RSV-confirmed lower respiratory tract disease and 94.1% effective against severe disease.
Both GSK and Pfizer have an FDA decision date of May. Moderna, which is also in the RSV running, is yet to apply for approval.